Class Class II
Persona™ Personalized Knee System (K230321)
Description
Persona™ Personalized Knee System by Zimmer, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230321
Clearance Date2023-03-08
Clearance TypeSpecial
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230321
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Persona™ Personalized Knee System (K230321) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 |
| K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | 2018 |
| K113369 | ZIMMER PERSONA KNEE SYSTEM | Zimmer, Inc. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 |
Trace the full predicate network for K230321
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.